An interventional study of Physiomesh in Hernia, Abdominal, Recurrence and Postoperative Complications, sponsored by Zealand University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by Zealand University Hospital · Not applicable, Interventional, and Treatment
The primary aim of the present study was to show how a national clinical register combined with other nationwide administrative registers may serve as a tool for pre- and post-marketing evaluation of new mesh and mesh fixation products for hernia surgery, using Physiomesh® versus other meshes designed for laparoscopic hernia repair as an example.
All adult (≥18 yrs) patients registered in the Danish Hernia Database (DHB) who underwent elective primary laparoscopic incisional hernia repair between January 1st 2010 and December 31st 2016.
To obtain 100% follow-up data from DHB will be combined with administrative data from the Danish National Patient register.
Patients will be followed from initial hernia repair until reoperation for recurrence, death, emigration outside Denmark or end of follow-up (november 2017).
Physiomesh and other mesh repairs will be propensity score matched. Each patient in the Physiomesh® group will be matched with two patients treated with one of the other synthetic meshes. The Propensity score includes age, sex, year of surgery, diagnosis of chronic obstructive pulmonary disease, diagnosis of diabetes, diagnosis of obesity, Charlson comorbidity index and size of hernia defect
The primary outcome: Difference in risk for a reoperation for recurrence between patients operated with Physiomesh® and patients operated with another synthetic mesh designed for laparoscopic repair.
The secondary outcome will be rates of 30-day readmission, 30-day reoperation for complications (excluding hernia recurrence) as well as 30- and 90-day mortality.
82 studies on the registry are indexed under Hernia, Abdominal; 19 are open to participants now.
This study's enrollment of 3,338 is above the median of 90 across 48 interventional studies indexed under Hernia, Abdominal.
Browse Hernia, Abdominal studies →Zealand University Hospital is the lead sponsor of 236 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Patients undergoing laparoscopic incisional hernia repair reinforced with a Physiomesh.
Device: Physiomesh
Patients undergoing laparoscopic incisional hernia repair reinforced with other meshes than Physiomesh.
difference in risk for recurrence and postoperative complication
Also known as: other mesh
Re-operation for recurrence rate
Time frame: up to 84 months
30-day readmission rate
Time frame: 30 day
30-reoperation for complication rate
Time frame: 30 day
Ran from Jan 2010 to primary completion in Nov 2017, 94 months.
Of 31 interventional studies with no phase under Hernia, Abdominal, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 60. This study's 94 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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